Families Moving Forward (FMF) Connect Pro for Mental Health Providers
NCT05960461 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2025-06-05
Summary
The goal of this clinical trial is to test a new provider-assisted version of the caregiver Families Moving Forward (FMF) Connect app ("FMF Connect Pro") with mental health providers in the United States. In FMF Connect Pro, mental health providers learn to do routine screening for prenatal alcohol exposure, diagnose fetal alcohol spectrum disorders (FASD), and support families in using the FMF Connect caregiver app.
Two different training methods will be compared with a waitlist group in this study. The first training method involves 13-sessions of tele-mentoring using an Extension of Community Healthcare Outcomes (ECHO) approach. The second training method involves a self-directed approach in which providers will access similar content in any asynchronous format on a website.
The main questions this study aims to answer are:
* What is the proportion of agencies and providers who accept and participate in the clinical trial (Reach)?
* Do study groups differ on provider outcome measures of Effectiveness (clients screened/diagnosed), Adoption (provider change in knowledge, self-efficacy), Implementation (practice change, FMF Connect Pro Dashboard usage), and Maintenance of FASD-informed care practice change?
All mental health providers in the study will complete online assessments at study entry, 6 months, and 12 months.
Conditions
- Fetal Alcohol Spectrum Disorders
Interventions
- BEHAVIORAL
-
FMF (Families Moving Forward) Connect Pro
FMF Connect Pro is a program supported by mental health providers to increase access to care for children (ages 3 to 12) with fetal alcohol spectrum disorders (FASD) and their families. FMF Connect Pro teaches and supports providers in 3 main activities: 1. Routine screening of prenatal alcohol exposure (PAE) 2. Apply DSM-5 diagnostic criteria for "Neurodevelopmental Disorder Associated with Prenatal Alcohol Exposure (ND-PAE)" 3. Support caregivers using the FMF Connect app FMF Connect Pro involves a Provider Dashboard with several main sections: * Learning - includes content and additional resources to support providers in learning how to screen PAE, diagnose ND-PAE, and support families using the FMF Connect app. * Tools and Resources - includes: screening, diagnostic, and documentation templates; app tip sheets; workbooks; supporting articles, websites, and other resources * Clients - providers can track clients' progress using the FMF Connect app
- BEHAVIORAL
-
ECHO (Extension of Community Healthcare Outcomes) implementation.
Mental health providers participate in a 13-session tele-mentoring training program using the ECHO (Extension of Community Healthcare Outcomes) approach. Each session involves a brief didactic presentation and case-based learning using de-identified cases shared by participants. The curriculum teaches providers how to do FMF Connect Pro.
- BEHAVIORAL
-
Self-Directed Learning implementation.
Mental health providers complete 13 learning modules asynchronously on the FMF Connect Pro Dashboard. These modules include pre-recorded didactic content, brief exercises to assess learning, and additional resources. The curriculum teaches providers how to do FMF Connect Pro.
Sponsors & Collaborators
-
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
collaborator NIH -
University of Rochester
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-03-22
- Primary Completion
- 2027-04-30
- Completion
- 2027-04-30
Countries
- United States
Study Locations
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